HealthyPhase 1NCT03912441

First-In-Human Study to Evaluate Safety And Pharmacokinetics of Single Escalating Doses of BCD-147 (Bispecific Anti-HER2/HER2 Antibody) in Healthy Subjects

A Phase 1 study testing BCD-147 in people with Healthy, run by Biocad at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is an open-label, phase 1, "3+3 trial" of pharmacokinetics, safety and immunogenicity of BCD-147 (JSC "BIOCAD", Russia) after single administration of escalating doses in healthy male volunteers Read more about this study

Who is it for?: Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: BCD-147
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteRussia
Study dates: 30 Jan 2019to 30 Sep 2019
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Signed Informed Consent Form and the subject's ability to follow the Protocol requirements;
Male gender 18-45 years of age inclusively at the signing of the informed consent;
Body mass index (BMI) in the normal range (18.0 - 30.0 kg / sq.m.);
Left ventricular ejection fraction is at least 55% measured by echocardiography;
Volunteer's ability to follow Protocol's procedures;
Verified diagnosis: "Healthy" according to standard clinical, laboratory, and instrumental examination methods;

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Hemodynamic parameters within the normal range: systolic blood pressure (BP) in the range of 90-130 mm Hg., diastolic blood pressure in the range of 60-90 mm Hg., heart rate - 60-90 beats / min;
Consent of volunteers and their sexual partners with childbearing potential to use adequate contraception throughout the entire trial period. This includes the use of the 1st barrier method in combination with one of the following: spermicides, intrauterine device / oral contraceptives;
Volunteer's ability not to drink alcohol within 24 hours prior to the administration of the drug and throughout the entire trial period.

Who cannot join

Participation in any other clinical trial within 30 days before the signing of the informed consent for this clinical trial;
Any condition that prevents a patient from following the Protocol procedures (dementia, neurological or mental disorders, drug/alcohol abuse, etc.);
The inability of venous puncture for the collection of blood samples (e.g., due to skin diseases);
Any surgical procedures that have been transferred within less than 28 days before the signing of the informed consent or planned within 28 days after completion of study participation;
Presence of any disorders that, according to the researcher, may affect the pharmacokinetics and safety of the investigational drug;
HBV/HCV/HIV infection, active syphilis;

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Acute infection or the acute phase of chronic infection within 28 days prior the first dose of the investigational product; Active HBV/HCV/HIV infection, active syphilis;
Values of standard laboratory and instrumental indicators that go beyond the limits of laboratory standards adopted in the central laboratory;
Use of medicines that have a pronounced effect on hemodynamics, liver function, etc. (barbiturates, omeprazole, cimetidine, etc.) less than 28 days before the signing of informed consent and / or the need to take any medications throughout the entire study (except for the study drug);
Regular use and parenteral administration of any drugs, including non-prescription drugs, vitamins and dietary supplements, less than 14 calendar days before the signing of informed consent;
Known severe allergy (anaphylaxis or multidrug intolerance);
Hypersensitivity to any of the components of BCD-147;
Smoking of more than 10 cigarettes per day;
Use of more than 10 units of alcohol per week (1 unit of alcohol is equivalent to ½ liter of beer, 200 ml of wine or 50 ml of spirits) or anamnestic information about alcoholism, drug addiction or drug abuse, or positive tests for alcohol and / or psychotropic / narcotic substances during the screening visit;
Donation of 450 ml or more of blood or plasma within 60 calendar days prior to the signing of informed consent;
Cardiovascular disorders, including hypertension or hypotension;
Edema of the lower limbs within 14 days before the signing of the informed consent;
A history of clinically significant systemic diseases;
Use of intravenous antibiotics within 7 days before the signing of informed consent.

Trial locations and contacts

1 site in 1 country.

Russia1 site

Medical Center "Eco-Safety"
Saint Petersburg, 196143

Other trials in Russia

About this study

Official title: Open-label Non-Comparator Multicohort Trial of Pharmacokinetics, Safety And Immunogenicity of BCD-147 (JSC "BIOCAD", Russia) After Single Administration of Escalating Doses in Healthy Volunteers

This is an open-label, phase 1, "3+3 trial" of pharmacokinetics, safety and immunogenicity of BCD-147 (JSC "BIOCAD", Russia) after single administration of escalating doses in healthy male volunteers

Conditions: Healthy
Being tested: BCD-147

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BCD-147Biological
Bispecific anti-HER2 monoclonal antibody

Study groups in NCT03912441
Study group	Role	What they receive
BCD-147 Monotherapy Dose Level 1	Experimental	Not described Receives: Biological: BCD-147
BCD-147 Monotherapy Dose Level 2	Experimental	Not described Receives: Biological: BCD-147
BCD-147 Monotherapy Dose Level 3	Experimental	Not described Receives: Biological: BCD-147
BCD-147 Monotherapy Dose Level 4	Experimental	Not described Receives: Biological: BCD-147

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Tolerated Dose (MTD)
Measured: 28 days
The percentage of volunteers with treatment-emerged adverse events of any grade per NCI CTCAE 5.0
Measured: 28 days
The percentage of volunteers with treatment-emerged adverse events of grade 3 and higher per NCI CTCAE 5.0
Measured: 28 days
The percentage of volunteers with both binding and neutralizing antibodies
Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jan 201930 Sep 2019

First posted11 Apr 2019
Study start30 Jan 2019
Primary completion30 Sep 2019
Study completion30 Sep 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by BiocadThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03912441
Sponsor's protocol ID: BCD-147-1
Status last verified: Sep 2020
First submitted: 10 Apr 2019
Last updated: 18 Sep 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open-label Non-Comparator Multicohort Trial of Pharmacokinetics, Safety And Immunogenicity of BCD-147 (JSC "BIOCAD", Russia) After Single Administration of Escalating Doses in Healthy Volunteers
ClinicalTrials.gov ID: NCT03912441
Acronym / sponsor ID: BCD-147-1
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: BiocadIndustry (pharma, biotech, devices)
Study start: 30 Jan 2019 (actual)
Primary completion: 30 Sep 2019 (actual)
Study completion: 30 Sep 2019 (actual)
First posted: 11 Apr 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is an open-label, phase 1, "3+3 trial" of pharmacokinetics, safety and immunogenicity of BCD-147 (JSC "BIOCAD", Russia) after single administration of escalating doses in healthy male volunteers

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
BCD-147 Monotherapy Dose Level 1	Experimental	Biological: BCD-147
BCD-147 Monotherapy Dose Level 2	Experimental	Biological: BCD-147
BCD-147 Monotherapy Dose Level 3	Experimental	Biological: BCD-147
BCD-147 Monotherapy Dose Level 4	Experimental	Biological: BCD-147

Who may qualify

Ages: 18 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

Signed Informed Consent Form and the subject's ability to follow the Protocol requirements;
Male gender 18-45 years of age inclusively at the signing of the informed consent;
Body mass index (BMI) in the normal range (18.0 - 30.0 kg / sq.m.);
Left ventricular ejection fraction is at least 55% measured by echocardiography;
Volunteer's ability to follow Protocol's procedures;

Key exclusion criteria (19 listed)

Participation in any other clinical trial within 30 days before the signing of the informed consent for this clinical trial;
Any condition that prevents a patient from following the Protocol procedures (dementia, neurological or mental disorders, drug/alcohol abuse, etc.);
The inability of venous puncture for the collection of blood samples (e.g., due to skin diseases);
Any surgical procedures that have been transferred within less than 28 days before the signing of the informed consent or planned within 28 days after completion of study participation;
Presence of any disorders that, according to the researcher, may affect the pharmacokinetics and safety of the investigational drug;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BCD-147Bispecific anti-HER2 monoclonal antibody	Biological	BCD-147 Monotherapy Dose Level 1, BCD-147 Monotherapy Dose Level 2, BCD-147 Monotherapy Dose Level 3, BCD-147 Monotherapy Dose Level 4

Primary outcome

Maximum Tolerated Dose (MTD)
Time frame: 28 days
The percentage of volunteers with treatment-emerged adverse events of any grade per NCI CTCAE 5.0
Time frame: 28 days
The percentage of volunteers with treatment-emerged adverse events of grade 3 and higher per NCI CTCAE 5.0
Time frame: 28 days
The percentage of volunteers with both binding and neutralizing antibodies
Time frame: 28 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2020.
Individual participant dataSharing planned: No

Related trials for Healthy

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Roman A Ivanov study director

Vice President R&D, JSC BIOCAD

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BCD-147 in people with Healthy, run by Biocad at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose (MTD) (time frame: 28 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03912441.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2020.